Cleared Traditional

K211036 - Plus Medical Chemotherapy Gown (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211036 · Foshan Nanhai Plus Medical Co, Ltd. · General Hospital
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May 2022
Decision
392d
Days
Class 2
Risk

K211036 is an FDA 510(k) clearance for the Plus Medical Chemotherapy Gown. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Foshan Nanhai Plus Medical Co, Ltd. (Foshan, CN). The FDA issued a Cleared decision on May 4, 2022 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Foshan Nanhai Plus Medical Co, Ltd. devices

Submission Details

510(k) Number K211036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2021
Decision Date May 04, 2022
Days to Decision 392 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
264d slower than avg
Panel avg: 128d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Olivia Meng

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FYA Gown, Surgical

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